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Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women

This study has been completed.
Sponsor:
Collaborator:
SisterLove, Inc.
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00362375
First received: August 8, 2006
Last updated: April 27, 2010
Last verified: April 2010

August 8, 2006
April 27, 2010
May 2006
April 2008   (final data collection date for primary outcome measure)
Condom Use During Vaginal Sex With Any Male Partner [ Time Frame: Past 3 months ] [ Designated as safety issue: No ]
Percentage of women who used condoms during vaginal intercourse with any male partner during the past 3 months
  • Consistent condom use
  • sexual abstinence
  • sexual risk behaviors such as unprotected vaginal, anal, and oral sex with main or casual partners
  • having sex while under the influence of drugs and alcohol
  • number of sex partners
  • HIV knowledge
  • attitudes towards condom use
  • condom use intentions
  • reasons for taking an HIV test
  • ability to assess personal HIV/AIDS risk
  • condom use self-efficacy
Complete list of historical versions of study NCT00362375 on ClinicalTrials.gov Archive Site
  • HIV Testing and Receipt of Results [ Time Frame: Past 3 months ] [ Designated as safety issue: No ]
    Percentage of women who reported testing for HIV infection and received their test results during the past 3 months
  • HIV Knowledge [ Time Frame: current ] [ Designated as safety issue: No ]
  • Condom Use Self-efficacy [ Time Frame: current ] [ Designated as safety issue: No ]
  • Knowledge of HIV Test [ Time Frame: current ] [ Designated as safety issue: No ]
  • HIV testing behaviors
  • Receipt of HIV test results
  • Communication of HIV test results to spouse or other sex partners
Not Provided
Not Provided
 
Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women
Evaluation of the Healthy Love Workshop, an HIV Prevention Intervention for African American Women by SisterLove, Inc. in Atlanta, GA

The purpose of this program evaluation is to determine whether the Health Love Workshop, a group-level HIV behavioral intervention, reduces HIV-related sex risk behaviors and increases HIV protective behaviors of African American women and women of African descent. The intent of this program is to support an evaluation of the efficacy of the intervention and to provide feedback to the implementing organization to increase intervention effectiveness.

SisterLove, Inc. in Atlanta, Georgia, is evaluating its HIV/AIDS prevention intervention called the Healthy Love Workshop (HLW). The HLW targets African American women and women of African descent who are at risk for HIV infection and transmission. The HLW, which lasts 3 to 4 hours and is delivered during a single session, is a highly interactive workshop that aims to provide a safe environment in which women can learn about: a) the modes of HIV transmission, b) effective strategies for reducing one's risk for contracting or transmitting HIV or other STIs, c) opportunities to develop or enhance skills for self-assessing the risk level of sexual behaviors and the use of safer sex techniques, and d) how to develop an awareness of personal, community and social attitudes, beliefs and norms that influence women's relationships, sexual behavior, and decision-making. SisterLove will identify a minimum of 28 groups of women to participate in the evaluation, which will use a concurrent comparison design with block randomization. These groups will be typical of those that currently receive the HLW, including but not limited to sororities, friendship circles, church groups and other affinity-based groups. Fourteen of the 28 groups will participate in HLW as the intervention group; 14 of the recruited groups will participate in an HIV/AIDS 101 workshop (HIV 101) as the comparison group. Each group will contain about 15 women, thus approximately 420 women will participate in the evaluation. Outcome measures will assess HIV/AIDS knowledge, attitudes towards condom use and HIV testing, condom use intentions, personal HIV/AIDS risk assessment, self-efficacy for taking steps to prevent HIV transmission, consistent condom use, sexual abstinence, and reduction in other sexual risk behaviors. These outcomes will be measured at baseline, and after the intervention at 3- and 6-month follow-ups.

Eligible groups of women were randomly assigned to receive the intervention (15 groups; 161 women) or a comparison workshop (15 groups; 152 women). Behavioral assessments were conducted at baseline and at 3- and 6-month follow-ups. Among sexually active women at the 3-month follow-up, HLW participants were more likely than comparison participants to report having used condoms during vaginal sex with any male partner or with a primary male partner, and to have used condoms at last vaginal, anal or oral sex with any male partner. At the 6-month follow-up, HLW participants were more likely to report condom use at last vaginal, anal or oral sex with any male partner, and having an HIV test and receiving their test results. The study findings suggest that a single-session intervention delivered to pre-existing groups of black women is an efficacious approach to HIV prevention. This study also demonstrates that a CBO can develop and deliver a culturally appropriate, effective HIV prevention intervention for the population it serves and, with adequate resources and technical assistance, rigorously evaluate its intervention.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV Infections
  • Sexually Transmitted Infections
  • Behavioral: Healthy Love Workshop
    The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
    Other Names:
    • Healthy Love Party
    • Healthy Love
  • Behavioral: HIV/AIDS 101 Workshop
    The comparison workshop (named HIV101) was also delivered as a single session lasting 2-3 h, to groups of women about the same size and in settings similar to those used for the HLW. The HIV101 workshop consists of an opening, one module containing the same three HIV/STD-related components as the HLW (HIV/AIDS facts, STI facts, and the Look of HIV) and a closing. However, the presentation of this information used a didactic, lecture-style format, as opposed to the interactive approach used to deliver the HLW.
    Other Name: HIV101
  • Experimental: Healthy Love Workshop
    Single-session, small-group HIV prevention intervention
    Intervention: Behavioral: Healthy Love Workshop
  • Active Comparator: HIV101
    Single-session, small-group intervention providing facts regarding HIV/AIDS
    Intervention: Behavioral: HIV/AIDS 101 Workshop

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
313
April 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women of African descent (including African Americans, Caribbean, and African Immigrants)
  • Over the age of 18 years

Exclusion Criteria:

  • Women who are pregnant or planning to become pregnant
  • Do not speak English
  • Recent (past 6 months) participation in HIV prevention workshop
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00362375
CDC-NCHSTP-1927-4768, U65/CCU424514-02
No
Dazon Dixon Diallo, MPH, CEO, SisterLove, Inc.
Centers for Disease Control and Prevention
SisterLove, Inc.
Principal Investigator: Dazon Dixon Diallo, MPH President/CEO SisterLove, Inc.
Study Director: Jeffrey H Herbst, PhD Project Officer, Division of HIV/AIDS Prevention, NCHHSTP, CDC
Study Director: Thomas M Painter, PhD Project Officer, Division of HIV/AIDS Prevention, NCHHSTP, CDC
Centers for Disease Control and Prevention
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP